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A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes (DUAL™ II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01392573
First received: July 7, 2011
Last updated: January 20, 2017
Last verified: January 2017

July 7, 2011
January 20, 2017
November 2011
October 2012   (Final data collection date for primary outcome measure)
Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]
Observed mean change from baseline in HbA1c after 26 Weeks of treatment.
Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]
Complete list of historical versions of study NCT01392573 on ClinicalTrials.gov Archive Site
Change in Body Weight [ Time Frame: Week 0, week 26 ]
Observed mean change from baseline in body weight after 26 Weeks of treatment.
Change in Body Weight [ Time Frame: Week 0, week 26 ]
Not Provided
Not Provided
 
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes
A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec/liraglutide
    IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily.
  • Drug: insulin degludec
    IDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDeg is injected subcutaneously (under the skin) once daily.
  • Experimental: IDegLira + metformin
    IDegLira was injected subcutaneously once daily for 26 weeks.
    Intervention: Drug: insulin degludec/liraglutide
  • Experimental: IDeg + metformin
    IDeg was injected subcutaneously once daily for 26 weeks.
    Intervention: Drug: insulin degludec
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
413
October 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with type 2 diabetes
  • HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
  • Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
  • BMI (Body Mass Index) more than or equal to 27 kg/m^2

Exclusion Criteria:

  • Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
  • Impaired liver function
  • Impaired renal function
  • Screening calcitonin equal to or above 50 ng/l
  • Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
  • Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures
  • Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)
  • Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion
  • History of chronic pancreatitis or idiopathic acute pancreatitis
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Denmark,   Hungary,   India,   Slovenia,   Switzerland
 
 
NCT01392573
NN9068-3912
2011-002336-72 ( EudraCT Number )
U1111-1121-4897 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP